Tissue dilator devices, methods of fabrication of tissue dilators, and methods of use for tissue dilators

ABSTRACT

The invention is directed to devices and methods for tissue dilators. In preferred embodiments, the dilators are particularly advantageous for use as a nasal dilator for dilating or supporting tissues overlying a nasal passage. The present invention relates to tissue dilator devices, methods of fabrication of tissue dilators, and methods of use for tissue dilators. In particular, the present invention relates to a wide variety of tissue dilators adapted to be coupled to dilate interior nasal passages of a subject including the vestibule and/or the valve thereof. The present invention is not intended to be limited to the illustrated or described embodiments as they are intended merely to assist the reader of this disclosure in understanding the subject matter of the invention described, taught, enabled and depicted herein. As for tissue dilator devices, the present invention encompasses a large variety of discrete structure, all intended to be applied externally to a subject for the purpose of dilating, or lifting, tissue adjacent to nasal passageways of the subject, including the vestibule and/or the valve of the subject so as to decrease resistance to inhalation and exhalation of said subject during respiration. The tissue dilators of the present invention include those having at least one resilient member providing a first biasing force, or restoring force, so that when mechanically coupled to dilate adjacent tissue of a subject, the dilator constantly exerts a force developed to return the resilient member to an unbent state. In addition, a second biasing force may be applied to assist in producing a desired dilation of tissue of a subject that acts in concert with the first biasing force to impart an additional amount of force to dilate tissue of a subject. As for methods of fabrication of tissue dilator devices, the present invention teaches and enables those of skill in the manufacturing art to rapidly and efficiently produce the tissue dilator devices described herein. That is, in addition to existing methods and techniques for fabrication of tissue dilators, the present invention add several new methods and techniques for fabricating tissue dilators according to the present invention. As for methods of use of such tissue dilators, the present invention teaches and enables several inventive methods of use of tissue dilators for the devices described herein.

[0001] This application for utility patent coverage in the United Statesof America hereby incorporates by reference and, under 35 U.S.C.§119(e), claims the benefit of the contents and filing dates accordedthree (3) U.S. Provisional patent applications bearing application Ser.Nos. 60/215,024; 60/214,995; and 60/221,108 and filed on Jun. 29, 2000,Jun. 29, 2000 and Jul. 27, 2000, respectively. All three (3) said U.S.Provisional applications are commonly entitled, “Tissue Dilators andMethods.”

FIELD OF THE INVENTION

[0002] The present invention is directed to tissue dilators. Inpreferred embodiments, the tissue dilator devices, methods offabrication of tissue dilators, and the methods of use for tissuedilators are particularly advantageous for use as nasal dilators forsupporting nasal tissues or dilating nasal tissues overlying nasalpassages such as the valve and/or the vestibule portion of such nasalpassages.

BACKGROUND OF THE INVENTION

[0003] The present invention is directed to externally applied tissuedilators and methods of fabrication and use of such external tissuedilators to dilate nasal tissue of a subject. Some examples of presentlyknown nasal dilators are disclosed in, for example, U.S. Pat. Nos.5,476,091; 5,533,503; 5,546,929; 5,549,103; 5,553,605; 5,611,333; and5,653,224, the entire disclosures of which are incorporated herein byreference.

SUMMARY OF THE INVENTION

[0004] The present invention relates to tissue dilator devices, methodsof fabrication of tissue dilators, and methods of use for tissuedilators. In particular, the present invention relates to a wide varietyof tissue dilators adapted to be coupled to a local tissue region of anose to dilate interior nasal passages of a subject including thevestibule and/or the valve thereof. The present invention is notintended to be limited to the illustrated or described embodiments asthey are intended merely to assist the reader of this disclosure inunderstanding the subject matter of the invention described, taught,enabled and depicted herein. For example, whether or not a singledilator device is depicted as adhered to a local tissue region of asingle nose, more than one device, and different such dilator devicesmay couple to a single nose to create a desired level of dilation ofsaid nose. Also, in those embodiments depicting a resilient member orregion of resiliency to promote dilation more than a single suchresilient member or region of resiliency may be utilized within or inconjunction with a single supporting body adhered to a local tissueregion. Said resilient member(s) or regions of resiliency may bediffering size, area, thickness, length or shape while still remainingwithin the purview and scope of the present invention. Likewise, use ofone or more release layers in conjunction with pressure sensitive orother adhesives preferably used in conjunction with the inventivedilator devices of the present invention may be used to enhance theshelf life, ease of use and shipment, comfort to a user and the like asis presently known and used in the art. Furthermore, the presentinvention draws upon the long and continually developing art and scienceof extrusion for certain of the embodiments of the present invention andone of skill in such art and science will readily appreciate theapplicability of certain of said embodiments to such manner offabrication. The inventors hereof assert that an ideal manner ofexternal nasal dilation preferably provides a lifting force orthogonalto the local tissue region, but some of the embodiments of thisinvention provide a tensing force (or surface tension across the planeof said local tissue region) so that a lower magnitude lifting forceproduces a desired amount of nasal dilation. Some of the embodiments ofthe present invention provide for reuse of certain components of thenasal dilators of the present invention so that other components may bereused. In these embodiments, the reuse may be only an additional reusewhile others may provide for long term “reuse” of the entire nasaldilator. In some regard, the devices depicted, taught, enabled anddisclosed herein are representative of entire families of new, usefuland non-obvious tissue dilators having a variety of alternateembodiments. As a result of a single or a few illustrations of one ormore such alternative embodiment, the remaining alternate embodimentsshould not be restricted, but rather are expressly covered hereby.

[0005] As for tissue dilator devices, the present invention encompassesa large variety of discrete structure, all intended to be appliedexternally to a subject for the purpose of dilating, or lifting, tissueadjacent to nasal passageways of the subject, including the vestibuleand/or the valve of the subject so as to decrease resistance toinhalation and exhalation of said subject during respiration. The tissuedilators of the present invention include those having at least oneresilient member providing a first biasing force, or restoring force, sothat when mechanically coupled to dilate adjacent tissue of a subject,the dilator constantly exerts a restoring force developed to return theresilient member to an unbent state. In addition, a second (oradditional) biasing force or forces may be applied in combination toassist in producing a desired dilation of tissue of a subject that actsin concert with the first biasing force to impart an additional amountof force to dilate tissue of a subject.

[0006] As for methods of fabrication of tissue dilator devices, thepresent invention teaches and enables those of skill in themanufacturing art to rapidly and efficiently produce the tissue dilatordevices described herein. That is, in addition to existing methods andtechniques for fabrication of tissue dilators, the present inventionadds several new methods and techniques for fabricating tissue dilatorsaccording to the present invention.

[0007] As for methods of use of such tissue dilators, the presentinvention teaches and enables several inventive methods of use of tissuedilators for the devices described herein, methods of use andapplication of such devices to a local tissue region and methods offabrication as well.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] In the following drawings elements having common attributes arereferred to with a common reference numeral even though illustratedembodiments having such common attributes may be patentably distinctfrom other of said illustrated embodiments.

[0009]FIG. 1 is one embodiment of a nasal tissue dilator devicespositioned on a nose according to the invention; and,

[0010]FIGS. 2 through 48 are alternative embodiments of a variety ofnasal tissue dilator devices positioned on a nose according to theinvention.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

[0011] The invention is directed to devices and methods particularlyadvantageous for use in supporting or dilating nasal tissues overlying anasal passage to thereby promote ease of respiration in a subject.

[0012] The devices and methods of the invention will be described byreference to the accompanying drawings in which oftentimes the sameelements are numbered the same throughout. The illustrated embodimentsand descriptions are provided only for exemplary purposes to facilitatecomprehension of the invention and should not be construed to limit thescope of the invention. The drawings are not described in sequentialorder, but are often referred to with respect to a common attribute ofthe embodiments described therein.

[0013] In FIGS. 1-38, the disclosed devices can include a base 1 whichis applied over a portion or all of the tissue to be supported ordilated. In some embodiments, an over-the-bridge component 2 can also bepresent. The over-the-bridge component 2 can be integral, separable, orindependent of the base 1. The over-the-bridge component 2 may furtherbe integral, separable, or independent of other components or elementsherein described. It will be appreciated that in some embodiments, base1 can be constructed to transfer or exert a force which can compress,tense, displace, support, stretch, shear, lift, etc. a portion or all ofthe tissue, and surrounding tissue, to which the base is applied.

[0014] It is to be understood that the following disclosure describes anumber of invention features or aspects through illustrations. Eachembodiment illustrated and described under a specific aspect maycomprise only that aspect or may comprise other aspects described inanother embodiment. For example, one device of the present invention maydisclose a multi-component dilator providing adjustable lifting dilationin a multi-directional manner.

Lifting Dilation

[0015] One aspect of the present invention relates to devices providinglifting dilation. Lifting dilation forces are forces directed outward(e.g. substantially perpendicular) from the tissue over the nasalpassages. A nasal dilator may for example include one lifting dilatorcomprising a base having a plurality of flaps. An over-the-bridgecomponent can be included, to provide lifting force to opposing skinportions, or local tissue regions, proximate nasal passages, such as thevestibule and valve portions of said nasal passages, to dilate saidnasal passages and improve flow of air therethrough. The base maycomprise, for example, a triangular frame as illustrated or other baseor frame shapes configured for facilitating tissue dilation. This typeof arrangement thus provides tissue dilation when, for example, thedevice is depressed and an adhesive on the flaps attaches to the skin ofthe nose; upon release, the flaps lift back to their original positionthereby dilating the nasal passage.

[0016] Lifting dilation can be achieved with or without use of anover-the-bridge component preferably formed of material having a degreeof resiliency so that when said component is bent to the contour of anose, a restoring force is exerted to further promote the liftingdilation. Of course, a lifting force providing dilation may be disposedon either side of a nose or only one side of a nose, or may couple tomore than one local tissue region on either side of a nose.

[0017] Referring now to FIG. 10, another lifting dilation embodiment ofthe present invention having a base 1 and a portion 7 which extends awayfrom the lateral aspect of the nose. The base 1 can include a perimeteradhesive surrounding a pad 1 c. As shown, for example, the base 1 isplaced on either side of the nose. Each portion 7 can then be secured ina position not directly over the bridge of the nose to provide adilation force. For example, the extending portion 7 can be positionedsimilar to how a medical mask with thin elastic headbands is worn.

[0018] Lifting dilation may also be achieved with devices, asillustrated in FIG. 8, comprising a base 1 and an over-the-bridgecomponent 2. The base 1 may include a pad 1 c. The over-the-bridgecomponent 2 may comprise a plastic dilating member 15. The plasticdilating member 15 in this arrangement provides lifting dilation forceby tending to return to a planar state after being forced from theplanar state by bending.

Multi-Directional Dilation

[0019] Another aspect of the present invention includes devicesproviding multi-directional dilation. Some dilators create liftingforces created from, for example, a spring member over the bridge of thenose tending to return to a planar state. As used herein, a“multi-directional” dilator also provides tensing forces. Tensing forcesare forces that stretch or extend the tissue overlying the nasalpassage. FIG. 1 illustrates one example of a multi-directional devicecomprising a base 1 and an over-the-bridge component 2. The base 1 inthis embodiment is bifurcated in a manner to exert a tensing force thatruns substantially parallel to the bridge of the nose (arrows) inaddition to lifting forces directed outward from the nasal passage. Inother embodiments, the over-the-bridge component 2 may or may notprovide an outwardly directed lifting force.

[0020] Without being limited to a particular theory, it is believed thattensing forces stretch the skin taut providing more dilation from thesame amount of force needed when the skin is not stretched taut. Thetensing forces can be located, for example, parallel to the bridge ofthe nose as illustrated in FIG. 1. It will be appreciated, however thattensing forces need not only be in the direction indicated by the arrowsof FIG. 1, but also in other directions which stretch or extend tissuealong the plane in which the base 1 lies. Tensing forces may be appliedalong the tissue in any direction to increase a device's dilationproperties.

[0021]FIG. 6 also discloses a multi-directional dilator comprising abase 1, an over-the-bridge component 2, and a wire-dilating member 3. Inthis embodiment, the wire-dilating member provides tension forcesrunning substantially parallel to the bridge of the nose (“out” arrows)in addition to outwardly directed forces (“up” arrow). In otherembodiments, the wire-dilating member 3 may or may not provide outwardlydirected lifting forces.

[0022] Adjustable Dilation

[0023] Another aspect of the present invention includes devicesproviding adjustable dilation. FIG. 2 shows one such embodiment having abase 1 and an over-the-bridge component 2. In this embodiment, theover-the-bridge component 2 comprises an elastic member 8, such aselastic bands 8 a. The elastic member 8 crosses over the bridge of thenose and attaches to the base 1. Dilation force can be adjusted whilethe dilator is being applied. For example, pulling on the elastic member8 to a selected position and then depressing an adhesive region 1 d onthe base 1 against the elastic member 8 secures the stretched elasticmember 8 to the base 1. Selectively stretching and securing the elasticmember adjusts the device's dilation level.

Variable Dilation

[0024] Another aspect of the present invention includes devicesproviding variable dilation. Variable dilation relates to dilatorscomprising multiple regions or components with more than one strength ofdilation force. FIG. 3 discloses one embodiment providing variabledilation. The illustration shows a device having a base 1 and anover-the-bridge component 2. The base comprises a foundational or firstregion 1 a and a second region 1 b. The first region 1 a may or may notprovide dilation forces over the bridge of the nose. The second region 1b can provide a stronger dilation force than the first region 1 a. Thedilation force of region 1 b in this embodiment extends outwardly fromthe nasal passages by upward lifting of region 1 b around an axisparallel to the bridge of the nose as indicated by hash marks.

Bi-Axial Dilation

[0025] Another aspect of the present invention includes devicesproviding bi-axial dilation. That is, the axis of dilation can beselectively positioned on the nose to a particular orientation toprovide a particular direction of lift. FIG. 3 also provides anotherexample of a bi-axial dilator. The axes are shown with hash marks. Asillustrated, embodiments can comprise a base 1 having a flap 1 b. Theflap 1 b provides the lift force for dilation on either side of the nosewithout the use of an over-the-bridge component.

[0026] Bi-axial dilation may also be achieved with devices, asillustrated in FIG. 5, comprising a base 1 having a flap 34 and anover-the-bridge component 2. The base 1 may be dilating or non-dilating.The flap 34 can provide dilating force on either side of the nose alongan axis running parallel to the bridge of the nose as illustrated withhash marks. For example, the flap 34 pulls the skin tissue outwardlyfrom the nasal passages along an axis parallel to the bridge of the noseto lift the tissue and dilate the nasal passage.

[0027] FIGS. 14-16 show other bi-axial embodiments. FIG. 14 illustratesa device comprising a base 1 and an over-the-bridge component 2. Thebase 1 further comprises a first base portion 1 e and a second baseportion 1 f. Dilation forces in this embodiment are created by thesecond base portion 1 f as opposed to dilation forces from theover-the-bridge component 2. The second base portion 1 f is undertension providing dilation forces around parallel axes (hash markedarea) on either side of the nose.

[0028]FIG. 15 illustrates another bi-axial device comprising a base 1having a first and second base portion 1 e and 1 f, an over-the-nosecomponent 2, and an elastic member 8. The elastic member 8 providesdilation by pulling or lifting the second base portion 1 f outwardly.The region similar to that region under tension as shown in FIG. 14 mayor may not provide tension in this arrangement. FIG. 16 illustrates anarrangement similar to FIG. 15 having components of different shape.

[0029] Another bi-axial dilator, as disclosed in FIG. 11, comprises abase 1, an over-the-bridge component 2, and an adjustment element 9.Adjustment element 9 adjusts or creates a force applied to, or near, aportion or all of the tissue to which the base 1 is applied. Theadjustment element 9 can, for example, attach to various locations onthe base 1 to provide for localized dilation. In this embodiment, theadjustment element 9 pops up or pinches the tissue over the nasalpassages in the direction shown by arrows. The pinching causes the nasalpassage to lift thereby providing dilation. The over-the-bridgecomponent 2 of this device may be dilating to provide multi-directionaldilation or may be non-dilating.

Multi-Component Dilation

[0030] Another aspect of the claimed invention includes devices havingmulti-components. Multi-component dilators essentially comprise a base,an over-the-bridge component, and a resilient member. The resilientmember may or may not be removable. FIG. 9 is an illustration of amulti-component dilator comprising a base 1, an over-the-bridgecomponent 2, and a removable resilient member 4. The base 1 includes acoupler 6 for receiving an end 5 of resilient member 4. Another similarembodiment is set forth at FIG. 23.

[0031] The coupler 6 for receiving an end 5 of the resilient member 4can be selected from, for example, a pocket, pouch, strap, tie, hook andloop, etc. The resilient member 4 may be selected from, for example,plastic, wire, elastic pieces, springs of various materials includingshape memory materials, splines, or any other components that producethe desired dilating forces.

[0032] In a multi-component embodiment having a removable resilientmember, the removable resilient member can be coupled with the basebefore or after application of the device to the nose. To illustrateuse, an adhesive, pocketed, non-dilating base can be applied to the noseand a removable resilient member then placed within pockets of the baseon either side of the nose. Once placed into the pockets and forced overthe nose from a planar state, the resilient member tends to return to aplanar state thereby producing dilating lift forces.

[0033] In another embodiment, the resilient member, such as amulti-directional resilient member, can be used to produce tensionforces that run, for example, parallel to the bridge of the nose inaddition to lifting forces. To illustrate, FIGS. 7 and 17 show somedevices comprising a base I having a plurality of couplers 6 forreceiving a removable resilient member 4 having a plurality of ends 5.This multi-directional arrangement increases the effectiveness of thedilator by providing both outwardly lifting forces as the resilientmember tends to return to a planar state and tension forces to stretchthe tissue in a direction parallel to the bridge of the nose.

[0034] The tension forces of multi-component devices may or may not bedirected along an axis running parallel with the bridge of the nose. Forexample, FIG. 13 illustrates a multi-component dilator including adilating base 1 and an over-the-bridge component 2 comprising aresilient member 4. This arrangement provides a tension force orstretching of the skin in a direction perpendicular to the bridge of thenose (arrows) as opposed to tension forces running parallel to thebridge of the nose.

[0035] Other multi-component embodiments are shown in FIGS. 12, 18, 19,22, 25-28, 32-37, each comprising various features. FIG. 12, forexample, illustrates a device having a bi-directional resilient member 4that provides a centering structure 4 a. The centering structure 4 afacilitates centering of the resilient member 4 on the bridge of thenose. A centering structure 4 a can be an integral or separablearrangement of, for example, an over-the-bridge component 2, a resilientmember 4, a base 1, or any other component of the present invention. Thecentering structure 4 a can further include, for example, a hump, arch,groove, indicator, taper, notch, etc.

[0036] Referring to FIG. 18, embodiments of the multi-component dilatorcan include various shaped bases 1, various shaped couplers 6, and, forexample, a removable resilient member 4 comprising a wire piece 4 b.FIG. 19 illustrates a multi-component embodiment comprising a removableresilient member 4 having a grasping member 4 c. The grasping member 4 ccan be selected from, for example, a rim, ridge, wedge, protrusion,notch, cutout, groove, or any other structure or device which allows auser to more easily grasp or handle a resilient member 4.

[0037]FIG. 22 discloses a multi-component device having a base I and anover-the-bridge component 2, and a resilient member 4 such as a wirepiece 4 b. Base 1 includes a coupler 6. This device also includes anadditional base 1′ having a coupler 6′ and a second dilating element 11.The wire piece 4 b connects with coupler 6 while the second dilatingelement 11 connects with both couplers 6 and 6′. The wire piece 4 bprovides outwardly lifting dilation forces while the second dilatingelement 11 provides tension forces. This arrangement increases theeffectiveness of the device's dilating properties by providingmulti-directional dilating forces.

[0038] In yet another embodiment, as shown in FIG. 25, a multi-componentdilator can comprise a base 1 having one or more securing elements 36. Asecuring element 36 can include, for example, a notch, hook, latch, pin,or any other element used to fasten or fix a dilating component. Thebase 1 can include, for example, integral securing elements or a meansfor fixation of independent securing elements. In the embodiment of FIG.25, the device comprises a base 1, an over-the-bridge component 2, and aplurality of elastic bands 8 a ; the base 1 further comprising aplurality of securing elements 36 to which one or a plurality (e.g. two)of elastic bands 8 a fasten or secure. The securing elements 36 of thisembodiment comprise notches located on the base 1 on either side of thenose. This arrangement provides for dilation on either side of the nosewithout dilation forces running over the bridge of the nose.

[0039]FIG. 32 discloses a base 1, an over-the-bridge component 2, aplurality of securing elements 36, and a plurality of elastic bands 8 a.The over-the-bridge component 2 includes a resilient member 4 havingends 5. In this arrangement, the elastic bands 8 a couple to securingelements 36 and tend to lift the upper and lower portions of the base 1.The lifting forces provide dilation of the nasal passage on either sideof the nose without dilation forces from across the bridge of the nose.The resiliency of the ends 5 in this embodiment creates an axis fromwhich the elastic bands 8 a lift.

[0040] In another embodiment, as shown in FIG. 26, an arrangement maycomprise a base 1, an over-the-bridge component 2, and an elastic member8 such as an elastic band 8 a, connected to a securing element 36 oneach side of the nose. The dilation forces in this arrangement runacross the bridge of the nose. As the elastic band 8 a tends to returnto its original position, the elastic band 8 a presses against anover-the-bridge component 2. The force against the over-the-bridgecomponent 2 causes the over-the-bridge component 2 to straighten therebyproviding lifting dilation.

[0041]FIGS. 33 and 34 disclose arrangements similar to FIG. 26 havinglower profiles to provide some users with more comfort. Of course, theuse or application of multiple devices according to the presentembodiments may be utilized. Another embodiment, as shown in FIG. 31,comprises a base 1 having an over-the-nose component 2, an elastic band8 a, and a plurality of securing elements 31. This arrangement alsoincludes a void 38 configured at or near the center of the dilatordevice. The void 38 separates dilating forces to also provide some userswith greater comfort.

[0042] A multi-component device can additionally provide selectiveincremental adjustment. The illustration in FIG. 27 discloses oneembodiment having a base 1, an over-the-bridge component 2, a securingelement 36, an elastic band 8 a, and a plurality of incrementally spacedadjusters 10. The adjusters 10 may include, for example, hooks, notches,protrusion, grooves, etc. The adjuster 10 can be integral with the base1 or over-the-bridge component 2 or be a separate component that fixesto the base 1 or over-the-bridge component 2.

[0043] To illustrate, as the elastic band 8 a is selectively positionedon the adjusters 10, the dilating force correspondingly adjusts. Forexample, placing the elastic member 8 a higher on the adjusters 10 ofthe over-the-bridge component 2 shown in FIG. 27 creates a strongerdilating force. The illustrated position shown in FIG. 31 provides forthe least dilating force. FIG. 28 discloses another adjusterarrangement. This embodiment provides for a triangular arrangement ofelastic bands 8 a lessening the potential of pinching and increasingsome user's comfort.

[0044]FIGS. 36 and 37 are all examples of multi-component dilatorembodiments having various features as described earlier. Thearrangements illustrated in FIGS. 36 and 37 provide for dilation lift toa larger area of skin on either side of the nose.

[0045] Referring to FIG. 35, the illustrated device combines thefeatures of a lifting dilator, a multi-component dilator, and a bi-axialdilator. The device comprises a base 1, a flap 34, a plurality ofsecuring elements 31, and an elastic band 8 a. The base 1 and flap 34can, for example, hinge at an axis that runs parallel to the bridge ofthe nose as shown by hash marks. The elastic band 8 a and securingelements can be arranged in a triangle configuration. When this dilatorarrangement is placed on the nose, the elastic band 8 a pulls up orlifts the flap 34 along the axis, thereby creating dilation force.

Spline-Only Dilation

[0046] Another aspect of the present invention includes devicesproviding spline-only dilation. A spline-only dilator may comprises abase and an over-the-bridge component. The over-the-bridge componentproduces a dilating force when placed directly over the bridge of thenose. This type of design can reduce the cost of producing dilatingdevices. FIGS. 30 and 38 are other examples of spline-only dilators thatalso provide a multi-directional feature. The illustrations disclose abase I having a flap 34 and an over-the-bridge component 2. Theover-the-bridge component 2 comprises a dilating spline member 13 thatproduces outwardly lifting dilation. The flap 34 provides a secondlifting dilation in the direction shown by the arrow, for example, inFIG. 38.

[0047]FIG. 29 shows a multi-component dilator having a base 1, anover-the-bridge component 2 comprising a spline dilating member 13, aplurality of securing elements 36, and a plurality of elastic bands 8 a.This device is essentially the same as a spline-only dilator havingmulti-direction dilation with dilating properties created by elasticbands 8 a as opposed to a flap.

Other Dilator Features

[0048] Referring to FIG. 4, some embodiments can include anover-the-bridge component 2 that comprises two layers of, for example,plastic to form an enclosed air pocket 14. The enclosed air pocket 14provides a low level bulge along the center of the dilator that whendeformed over the bridge of the nose, increases pressure within thepocket 14. Increased pressure within the pocket 14 increases liftingdilation. As with other devices disclosed herein, the over-the-bridgecomponent 2 can be made of clear plastic.

[0049] In some embodiments, such as that shown in FIG. 20, the devicecan comprise a base 1, an over-the-bridge component 2, and an elasticmember 8 bonded to base 1. In this arrangement, the elastic member 8produces dilation forces as the elastic member 8 contracts. The base 1may or may not provide additional dilating forces.

[0050]FIG. 21 illustrates an embodiment having a base 1, a firstover-the-bridge component 2, a second over-the-bridge component 2′, andan elastic member 8 such as an elastic band 8 a. The secondover-the-bridge component 2′ can comprise a plastic non-dilating piece.The elastic band 8 a of this arrangement is connected to the secondover-the-bridge component 2′ and provides dilation by contracting andlifting the second over-the-bridge component 2′.

[0051] The device illustrated in FIG. 24 discloses a base 1 and anover-the-bridge component 2 comprising an elastic member 8. The base 1can further comprise an adhesive pad 1 c. The elastic member 8 contractsthereby providing dilating force. It should be appreciated that thedilating force is adjustable. In essence, the dilating properties of thedevice become stronger the further the base 1 is placed from the bridgeof the nose. Some embodiments can include a portion of theover-the-bridge component which can be prepared from a resilientcushioning material, such as an open cell or closed cell foam. Dilationis produced when the foam contracts over the bridge of the nose causingthe skin to lift over the nasal passages.

[0052] Other features of the herein disclosed devices will beappreciated from the drawings. For example, a device including aresilient member prepared from an open cell or closed cell material maybe produced that optionally includes additional padding over at leastone end of the resilient member to increase comfort and decrease thelikelihood of painful contact proximate the nose of the user.Furthermore, the resilient member may include two or more resilientcomponents configured to form a void therebetween which reduces theamount of the device which rests on a user's nose. In this embodiment,an example of which is depicted at FIG. 45, and in addition to otherfeatures, including one or more alignment mechanisms for assisting auser in properly applying the dilator device to the nose. In FIG. 45,this alignment feature is illustrated as an indicator 60 which comprisesa port or aperture, although one or more such ports may be providedeither in a straight line or as a design or other indicia to assist theuser in applying the device.

[0053] Referring to FIG. 39, such an alignment feature comprises acentering arch 61 to facilitate positioning of the dilator over a nose.The device further illustrates large tapered and rounded tabs at theends to prevent accidental folding or curling of the ends duringplacement on the nose. FIG. 39 also illustrates a device with anindicator 60 in addition to other features and, as with most everyembodiment set forth in this disclosure the device may be applied across(or over) the nose either in the orientation as depicted in thedrawings, or inverted from the orientation depicted in the drawings.Other devices having a base may include wing features which when engagedto the local tissue region exert an upward force to the tissue tothereby dilate same.

[0054]FIG. 40 illustrates an alternative configuration for anover-the-bridge component 2 and an indicator 60.

[0055]FIG. 41 illustrates a device including a portion of base 1 and anover-the-bridge component 2 which can be elastic. In other relatedembodiments, the base and over-the-bridge component can all be made froman elastic material or from a resilient material.

[0056]FIGS. 42a-b depict an embodiment including a base member 1, havingan over-the-bridge portion 2 and having a series of apertures 45disposed along a longitudinal axis of the base member 1 so that aresilient body member 25 may be releasably coupled to, and received by,the apertures 45. In this embodiment, the resilient body member 25 maybe sized to fit in any two of said apertures 45 thereby providing anadjustable magnitude of lifting force to the base member 1. The ends ofresilient body member 25 may be formed to provide a friction fit to theapertures 45 or may be provided with adhesive material to promote themechanical coupling therebetween. In this embodiment several differentattachment mechanisms and materials may be utilized to create thedesired dilation. For example, many ports 45 may be provided in the body1 of the dilator to receive one or more elongate members. As depicted inFIG. 42a, a first upper member 25 may have resilient properties (i.e.,sustain a restoring force when bent or deformed from an original state)and may be directly coupled to any two ports 45 formed in the body 1 ofthe dilator. The member 25 may be one of a set of different members thateach provide a different magnitude restoring force so that a user mayselect an appropriate magnitude of lifting force as desired by the user.In addition, one or more addition members 25′,25″ may be coupled to thebody 1 or may be affixed or formed to receive the elongate first member25 through the ports 45. The additional members 25′,25″ may be formed ofa material different than the material of first member 25. Theadditional members may be formed of an elastic material and/or anadhesive material. As noted, these additional members may have aselected resilient (or elastic) force due to their chosen materialcomposition, their length and the location at which they couple to thebody 1. The additional members 25′,25″ may have portions formed toreceive and retain the ends of the first member 25, such a socket toreceive a corresponding ball portion of the first member 25, and thelike.

[0057] Other embodiments of a tissue dilator may have a dual set or moreresilient body members 25 with fastened with, for example, micro hookand loop type material on opposing sides of the body members so thatthey mechanically couple together and thus provide additional liftingforce when combined. The base member of such a device also may becovered with a complementary layer of such micro hook and loop materialto retain the first resilient body member to the exterior of the basemember. A related embodiment having a single resilient member coupled toan elastic member of similar dimension may also be provided according tothis embodiment. An adhesive layer of material is preferably provided onthe base member on the side opposite to the resilient body members topromote adhesion to a local tissue area and an additional layer ofadhesive. In these and other alternative embodiments of the presentinvention, the adhesive layer or portion that typically (and preferably)adheres the dilator to the local tissue region may be configured to bere-usable. In these embodiments, a pad member may slideably engage oneor more resilient members so that during use the combination is retainedin place. When the dilator device is removed by a user, the pad membersmay be manually removed and another substituted when the user is readyto apply another dilator device. The pad member may be adhered with areleasable adhesive, may be connected with a friction fit coupling, maybe attached with a screw or threaded shank and the like. The net benefitto the user relates in part to the fact that once the user locates aresilient member having a magnitude of restoring force desired by theuser, that same resilient member may be used on at least severaldifferent occasions with the same results. These embodiments allow forfabrication and use of a relatively expensive, customized resilientmember fabricated for a single user or a group of users who desire acertain magnitude of force or a certain size of resilient member (and inmost embodiments dilator device) that best promotes respiration for saiduser.

[0058] Other related embodiments relate to those just described , mayhave each end of a single resilient body member disposed in a set ofpockets formed at each end of the base member. These pockets may beadhered, or heat sealed, laminated, connected with hook and loopfasteners and the like. This embodiment allows a user to install avariety of different resilient body members to provide differing levelsof lifting force and/or having different physical dimensions to promotedilation of a local tissue region. Each one of said pockets may beretained with an adhesive or one side adhered and another fastened withmicro hook and loop type fastener material and an adhesive layer 3provides a means to couple the device to a local tissue region on atleast each end of the body 1.

[0059] Yet another embodiment related to those just discussed, wherein aresilient body member is disposed in a cavity formed by an top layer ofmaterial which is preferably heat laminated or adhered to mechanicallycoupled to retain the resilient body member within said cavity. A layerof adhesive material is disposed on the reverse side of the base memberto provide adhesion to a local tissue region. The cavity may be size toallow the resilient body member to move slightly within said cavity sothat no undue binding or wear occurs during use and/or during storage orshipment of the dilator devices to an end user.

[0060] Another related embodiment of the present invention as describedimmediately above, in which an additional elastic layer is providedintermediate the adhesive layer and the base member and wherein a pocketor cavity is formed to retain the resilient body member in place duringuse. As noted, heat lamination, micro hook and loop type fastenermaterial(s), or pressure sensitive adhesive may be used to fabricate thedevices in this series of related embodiments of the present invention.The additional elastic layer, provides added resiliency to the structureand, as depicted, the base member may be severed so that just an endportion is coupled to the elastic layer and the resilient body member.

[0061]FIGS. 43a-b depicts an embodiment of the present invention whereinthe base member 1 is two interlocking base member portions 1′,1″ andhave an integral resilient body member portion 25 formed as a part ofone of said two interlocking base member portions 1′,1″. An aperture 45formed in one of said interlocking members 1″ receives the resilientbody member portion 25 and the body member portion 25 is adhered to theother interlocking member 1′. This inherently adjustable device may thusbe manipulated and adjusted by a user to provide a varying amount oflifting force to a local tissue region and/or to provide a differentsize (i.e., length) to the assembly. In this embodiment, the lengthand/or the magnitude of the force promoting dilation may be adjusted bythe user after adhering each end of the device to respective localtissue regions proximate the nasal passages to be dilated. That is, theinterlocking members 1′, 1″ are not adhered to each other (i.e., arelease liner is retained in place) and the user pulls said members 1′,1″ together and then adheres them to each other when they sense adesired magnitude of force applied to the local tissue region.

[0062]FIG. 44 depicts an embodiment of the present invention wherein theover-the-bridge portion 2 of the base member 1 is pre-formed into adesired single curve shape and the ends of the base member 1 aresubstantially straight. A pair of bonding pads 3 provided with anadhesive material disposed on the exterior surface thereof are coupledto the ends of the base member 1 to retain the device in place proximatea local tissue region during use. In the embodiment depicted at FIG. 44,the pair of bonding pads 3 are connected to the base member 1 with asmall extension member 7 affixed to the side of the pre-formed basemember and when coupled to the local tissue region the pre-formedover-the-bridge portion 2 is bent back toward the single curve shape tothereby promote a lifting force substantially orthogonal to the surfaceof the local tissue region. In the embodiment depicted (in part) in FIG.44b, in lieu of the bonding pad and the small extension member 7 thebase member 1 has a formed portion or area 3′ that provides for astand-off boss area upon which adhesive material is applied, butotherwise performs a similar function to that set forth by the bondingpads 3 depicted in FIG. 44a. The extension member 7 may be formed of anelastic material such as closed cell form to absorb and distribute thelifting force of a resilient member coupled thereto and/or to promotethe desired orthogonal lifting force to the local tissue region.Alternatively, the extension member 7 may be formed of a relativelyrigid material additional to more fully transmit the lifting force ofthe resilient member. Of course, the small extension member 7 may beformed integrally to the entire dilator device so that said extensionmember 7 is a ridge, or boss 7, of material extending above, or spacedapart from, the general planar portion adjacent to said member 7. Inthis regard, the member 7 may be additional material or may beessentially the same thickness as the rest of the adjacent portion ofthe dilator device (i.e., hollow or without structure disposedunderneath said member 7).

[0063] Referring now to FIG. 45, a dilator device 10 of the inventioncan include one or more resilient members 1, a surface layer 2 on afirst side of the device and an adhesive layer 4 on at least a part of asecond side of the device for securing the device to a local tissueregion. A port 60 (or a plurality of ports 60—not shown) may be providedto facilitate alignment as earlier described herein. The resilientmember(s) 1, surface layer 2 and adhesive layer 3 can be made frommaterials and assembled as disclosed in, for example, U.S. Pat. Nos.5,533,499 and 5,549,103 the entire contents of which are herebyincorporated by reference herein.

[0064] Referring to FIG. 45, a complex shape resilient member 1 havingmajor portions spaced apart and coupled with short segments, orcontinuous portions 4, coupling the spaced apart major portions helpsprovide a distributed lifting force to the local tissue area. A relatedembodiment to that depicted in FIG. 45 having such continuous portions 4only coupling the major portions of the resilient member intermediate(and not at or proximate the ends thereof) provides even more evenlydistributed lifting force (and allows the ends portions to individuallylift the proximate local tissue region thereof. Of course, more than twomajor portions may be created and each may or may not be coupled to eachof the other of said major portions. It will be appreciated that thatembodiment of the device 10 of FIG. includes a plurality of continuousportions 4 between resilient members 1 although a single such portion 4may be provided coupling adjacent major portions.

[0065] Referring to FIG. 46, an alternative embodiment of a device 20according to the present invention is illustrated fabricated usingextrusion methods of manufacture. In this embodiment, a resilient body25 of device 20 can be punched from an extruded plastic bar using knownmethods including those disclosed, for example, in U.S. Pat. No.6,029,658. The extrusion can be either the long axis or the short axisof a device 20. An adhesive can then be applied to form adhesive layer26 or an adhesive material may be co-extruded at the same time theextruded plastic (or other material) bar is produced. Alternatively, thebar of extruded material may itself be formed of a suitable adhesivematerial so that the entire device 20 including the body 25 of thedevice 20 are rendered adhesive. It will be appreciated that a surfacelayer (not shown) can also be applied to the device 20, which isparticularly desirable in the event that the device 20 itself isentirely rendered of adhesive material.

[0066] In another embodiment illustrated in FIG. 4, a device 30 caninclude at least two different components which are co-extruded orextruded separately and then combined into an integral article usingknown methods. As illustrated, a first component 35 can be co-extrudedwith a second component 36 or the first component 35 and the secondcomponent 36 can be separately extruded and subsequently combined.Additional components can also be extruded (co-extruded or“tri-extruded” and the like). A layer of adhesive material may beapplied to one side and a protective surface layer (not shown) may bedisposed on a second side of device 30, or, as noted above, an adhesivematerial may be combined with the original extrusion material to renderat least one side of the device 30 adhesive.

[0067] Thus, for example, in this embodiment, device 30 can include aresilient polyurethane component 36 and an open cell or closed cellplastic component 35 (such as an open cell or closed cell polyurethane)to facilitate use comfort at a location where a device 30 extends overthe bride of a nose (or other local tissue region) to be dilated. Thematerial chosen for this embodiment may itself be adhesive in nature(and may be optionally covered entirely or on a side thereof with arelease layer).

[0068] Alternatively, referring to FIG. 48, component 36 can provide fora first amount of resiliency and component 35 a second amount ofresiliency, the resiliency of components 35 and 36 can be the same ordifferent in magnitude. Illustrated by reference to FIG. 48 is anotheralternative embodiment of a first component 35 and a second component 36having a substantially planar centrally-located resilient region whichis best fabricated using the “short axis” extrusion methods elsewheredescribed herein. In this embodiment, a closed bubble or cavity open toambient pressure may be formed in the middle or near the ends of themember 30 to promote comfort and assist in directing the lifting forceto the preferred orthogonal orientation relative to the local tissueregion.

[0069] The materials forming extruded component 35 can be the same or,typically, different than that of extruded component 36. Examples ofmaterials suitable for extruded components 35 and 36 include, withoutlimitation, thermoplastic resins such as poly(acrylonitrile-co-butadience-co-styrene) polymers, acrylic polymers suchas polymethylmethacrylate, poly-n-butyl acrylate, poly(ethylene-co-acrylic acid), poly (ethylene-co-methacrylate), etc.;fluoropolymers including polytetrafluoroethylene (i.e., teflon®), poly(ethylene-co-tetrafluorethylene) co polymers,(tetrafluoroethylene-co-propylene) copolymers, polyvinyl fluoridepolymers, etc., polyamides such as nylon 6, nylon 6,6 etc.;polycarbonates; polyesters such as poly(butylene-co-terephthalate);poly(ethylene-co-1,4-naphthalene dicarboxylate),poly(butylene-co-terephthalate), polyimide materials; polyethylenematerials including low density polyethylene; linear low densitypolyethylene, high density polyethylene, high molecular weight highdensity polyethylene, etc.; polypropylene, biaxially orientedpolypropylene; polystyrene, biaxially oriented polystyrene; vinyl filmsincluding polyvinyl chloride, (vinyl chloride-co-vinyl acetate)copolymers, polyvinylidence chloride, polyvinyl alcohol, (vinylchloride-co-vinylidene dichloride) copolymers, specialty films includingpolysulfone, polyphenylene sulfide, polyphenylene oxide, liquid crystalpolyesters, polyether ketones, polyvinylbutyrl, and the like.

[0070] Referring now to yet other embodiments of the present invention,a dilator device may include one or more resilient members, a surfacelayer, an adhesive layer and an alignment guide such as an orifice oraperture, reflective indicia, a design, a series of apertures, a linearindiciate, a ridge, a boss and the like that is readily detected by theuser of the dilator and assists such user in accurately aligning andapplying said dilator. In this embodiment, the alignment guide may becentrally located in a transverse dimension along a longitudinal axis ofthe device and can thus facilitate positioning of the device whenapplying the device over the bridge of a nose, or other local tissueregion to be dilated. It will appreciated that the alignment guide (orguides) need not be positioned on the longitudinal axis and may beconfigured of a wide variety of features to assist the user in applyingthe device accurately to the local tissue region. Device may include oneor more apertures (not shown) in alignment, or may comprise a ridge,reflective indicia, geometric indicia, design indicia, an apex feature,a boss, or a region of increased thickness, as mentioned above.

[0071] In yet another embodiment of dilator devices of the presentinvention, it will be appreciated that the alignment guide can also bepositioned along a continuous portion extending between one or moreresilient members1 disposed on said dilator.

[0072] From the foregoing detailed description and examples, it will beevident that modifications and variations can be made in the productsand processes of the invention without departing from the spirit orscope of the invention. Therefore, it is intended that all modificationsand variations not departing from the spirit of the invention comewithin the scope of the claims and their equivalents.

We claim:
 1. A device for supporting tissue substantially perpendicularto the surface of said tissue, comprising: a first multifunctional basemember having a perimeter structure composed of at least three spacedapart segment portions individually adapted to mechanically couple to afirst local tissue area and at least one of said at least three spacedapart segment portions has a flap portion mechanically coupled thereto;and, said flap portion has an adhesive material disposed therein topromote adhesive contact between said flap portion and said first localtissue area.
 2. A device according to claim 1, further comprising: asecond multifunction base member adapted to mechanically couple to asecond local tissue area; and, a resilient member coupled to the firstmultifunction base member and the second multifunction base member.
 3. Adevice according to claim 2, wherein the resilient member couples to theperimeter structure.
 4. A device according to claim 3, wherein theresilient member couples to the flap portion.
 5. A device according toclaim 1, wherein the flap portion is at least three flap portions.
 6. Adevice according to claim 1, further comprising: a resilient membercoupled to the first multifunction base member and a patch of tissueadjacent the local tissue area so that the local tissue area is biasedin a direction substantially orthogonal to the surface of said localtissue area.
 7. A device according to claim 2, wherein the resilientmember is partially coiled in a first direction proximate the firstmultifunction base member and a second direction intermediate to thefirst multifunction base member and the second multifunction basemember.
 8. A device according to claim 7, wherein the resilient memberis partially coiled in a second direction, opposite the first direction,over an intermediate segment of said resilient member interposed betweensaid first multifunction base member and said second multifunction basemember.
 9. A device according to claim 7, wherein said firstmultifunction base member and said second multifunction base member areintegral pads having an adhesive material affixed to one side thereof.10. A device according to claim 8, wherein said first multifunction basemember and said second multifunction base member are integral padshaving an adhesive material affixed to one side thereof.
 11. A deviceaccording to claim 2, wherein said resilient member is at least a selectone of the following: an elongate elastic strap, a rubber band, asegment of fiber, a segment of fiber-reinforced material, a wire, asegment of metal, a segment of metallic alloy, a segment of compositematerial, a spring, a segment of pre-formed resin, a segment of plastic,or a segment of fabric.
 12. A device according to claim 11, wherein saidfirst multifunction base member and said second multifunction basemember are integral pads having an adhesive material affixed to one sidethereof.
 13. A device for providing a lifting force to a local tissuearea, comprising: a tensing force structure mechanically coupled to atleast a portion of a periphery of a local tissue area for creating atensioning force across a portion of said local tissue area; and, alifting force structure mechanically coupled to the tensing forcestructure so that the tensing force structure is biased away from saidlocal tissue area.
 14. A device according to claim 13, wherein saidtensing force structure is a first multifunctional base member having aperimeter structure composed of at least two spaced apart segmentportions individually adapted to mechanically couple to the periphery ofthe local tissue area and at least one of said at least two spaced apartsegment portions has a flap portion mechanically coupled thereto.
 15. Adevice according to claim 14, further comprising: a second multifunctionbase member adapted to mechanically couple to a second local tissuearea; and, a resilient member coupled to the first multifunction basemember and the second multifunction base member.
 16. A device accordingto claim 15, wherein the first multifunctional base member, the secondmultifunctional base member and the resilient member are formed as anintegral unit.
 17. A device according to claim 10, wherein saidresilient member mechanically adjustably couples to at least one of saidfirst multifunctional base member or said second multifunctional basemember.
 18. A device according to claim 17, wherein the adjustablecoupling comprises a friction fitting which compressibly retains theresilient member in place.
 19. A device according to claim 17, whereinthe adjustable coupling comprises an elastic flap having adhesive on asurface of said elastic flap and said elastic flap produces anadditional lifting force independent of any force provided by theresilient member.
 20. A device according to claim 1, further comprisingat least one adjustable coupling comprising an elastic flap has anadhesive on a surface of said elastic flap and said elastic flapproduces an additional lifting force independent of any force providedby the at least one flap member.
 21. A device according to claim 2,wherein said resilient member couples to at least one of said firstmultifunctional base member or said second multifunctional base memberusing at least a select one of: stitching, a pocket portion disposed oneither of said multifunctional members, adhesive, solder, thermalbonding or using a pair of hook and loop style fastener patches.
 22. Adevice according to claim 1, further comprising an intermediateresilient member disposed across the local tissue area and coupled tothe first and second of the at least a first and second of the at leastthree spaced apart segment portions.
 23. A dilator device, comprising: abase member having a first attachment location and a second attachmentlocation on a first major surface and an adhesive material on at leasttwo portions of a second major surface opposite the first major surface;and, a resilient member mechanically coupled to the first attachmentlocation and the second attachment location.
 24. A dilator deviceaccording to claim 23, further comprising an intermediate attachmentlocation disposed between the first attachment location and the secondattachment location and adapted to adjustably receive an intermediateportion of said resilient member.
 25. A dilator device according toclaim 24, wherein said first attachment location, said second attachmentlocation and said intermediate attachment location are all disposed onthe first multifunction base member.
 26. A dilator device, comprising:an elongate resilient member having a first end and a second end; a basesubstrate coupled to the elongate resilient member and having anadhesive material disposed over at least two patches of a surfacethereof; and, a portion of padding material affixed to either the firstend or the second end of the resilient member.
 27. A device according toclaim 26, wherein the base substrate is padded and devoid of adhesive inan intermediate location disposed between the at least two patches. 28.A device according to claim 26, further comprising a mountingorientation guide member disposed in a middle portion of the basesubstrate.
 29. A device according to claim 28, wherein said mountingorientation guide member is either an enlarged portion of said basesubstrate or at least one aperture formed in said base substrate.
 30. Adevice according to claim 26, wherein said elongate resilient member andsaid base substrate are a common elongate structure having an enlargedhead feature at each end thereof and said adhesive disposed over atleast two patches of a surface thereof is disposed at least proximateeach end thereof and said padding member is at least an area devoid ofadhesive.
 31. A device according to claim 26 wherein said base substrateis perforated with at least two perforations.
 32. A method offabricating tissue dilator devices, comprising the steps of: extruding aseries of units of a set of thin forms each having at least a resilientportion and optionally having an area of reduced thickness; and,providing a perforation between at least two successive units of the setthin forms providing for manual separation of said two successive units.33. A method according to claim 32, further comprising the step of:periodically cutting said series of units.
 34. A method of claim 32,wherein said at least a resilient portion extends to each end of atleast one of said series of units.
 35. A method according to claim 32,wherein said at least a resilient portion is and elongate structuredivided along and providing a periphery around a longitudinal axisaperture.
 36. A method according to claim 35, wherein said longitudinalaxis aperture is an interior bubble cavity added during the extrudingstep and open via at least one end to ambient pressure.
 37. A methodaccording to claim 33, wherein said periodic cutting provides at leastone enlarged end portion of reduced thickness.
 38. A method according toclaim 37, further comprising the step of: forming each of said unitsinto a preformed shape.
 39. A method according to claim 38, wherein saidpreformed shape is a continuously curving shape.
 40. A method accordingto claim 33, further comprising, in addition to said cutting step, thestep of forming at least one aperture in each of said units.
 41. Amethod according to claim 40, wherein said at least one aperture isformed substantially intermediate a first end and a second end of eachof said units.
 42. A dilator device formed by extrusion processing,comprising: a resilient member having a first end and a second end; and,a patch of adhesive material disposed at said first end and said secondend.
 43. A method of fabricating dilator devices, comprising the stepsof: combining a first material resilient a second adhesive material;co-extruding said first resilient material and said second adhesivematerial; and, perforating a portion of said co-extruded materialbetween an initial dilator unit and a subsequent dilator unit.
 44. Amethod according to claim 43, wherein said first resilient material andsaid second adhesive material are the same material.
 45. A method of usefor a tissue dilator, comprising the steps of: aligning an alignmentfeature of a tissue dilator with the nasal ridge portion of a subject;compressing the tissue dilator on each side of said alignment feature toa local tissue region.
 46. A method according to claim 45, furthercomprising the steps of: adjusting an adjustable member of said tissuedilator to increase or decrease a lifting force imparted by said tissuedilator to the local tissue region.
 47. A method according to claim 46,wherein said adjustable member is a select one of an elastic member, arubber band, a segment of metal, a metallic alloy, an extruded unit, afibrous material, a segment of cloth, an elongate ribbed material, anelastic flap member having adhesive disposed thereon, or a wire.
 48. Amethod according to claim 46, further comprising the step of: adjustinga secondary adjustment mechanism of said tissue dilator to increase ordecrease a tensing force imparted across a surface of the local tissueregion.
 49. A method according to claim 48, wherein said adjusting ofthe secondary adjustment mechanism comprises the steps of: stretching anelastic flap member which is mechanically coupled at an edge of saidelastic flap member to said adjustable member; and adhering said elasticflap member to an adjacent portion of the local tissue region.
 50. Atissue dilator, comprising: an adhesive layer; a bottom layer; a tensionspline member; and, an enclosing top layer.
 51. The tissue dilator ofclaim 50, wherein said tension spline member is disposed in a cavitydevoid of adhesive formed between the bottom layer and the enclosing toplayer.
 52. The tissue dilator of claim 51, wherein said cavity in whichthe tension spline member is disposed is larger in area than the tensionspline member so that said tension spline member may move within saidcavity.
 53. The tissue dilator of claim 52, wherein the enclosing toplayer is two layers and said tension spline member is disposed in apocket formed by each of the two layers of said enclosing top layer. 54.A tissue dilator device, comprising: a first interlocking spline memberhaving an spline-receiving slot formed therein; a second interlockingspline member configured at a first end to be inserted into thespline-receiving slot; and wherein a portion of said first interlockingspline member and a portion of said second interlocking spline memberhave an adhesive material disposed therein to adhere to a local tissuelocation of a subject.
 55. A device according to claim 54, wherein asecond end of the second interlocking spline member disposed opposite ofthe first end of the second interlocking spline member is an enlargedhead portion having an adhesive layer covering a portion of saidenlarged head portion.
 56. A device according to claim 54, wherein asecond end of the second interlocking spline member disposed opposite ofthe first end of the second interlocking spline member is an elongateresilient member mechanically coupled to said enlarged head portion. 57.A device according to claim 56, wherein said elongate resilient membercomprises a curved member.
 58. A device according to claim 57, whereinsaid elongate resilient member is a continuously curved member.
 59. Adevice according to claim 54, further comprising an alignment elementdisposed near a central location of said tissue dilator device.
 60. Adevice according to claim 59, wherein said alignment element is a selectone of an aperture, a ridge feature, a boss, a reflective member, alinear indicia, a design indicia, an apex feature or a region ofincreased thickness.